FDA WARNING_LETTER - Green Pharmaceuticals Inc. - June 09, 2022

The FDA issued a Warning Letter to Green Pharmaceuticals, an OTC human drug manufacturer, following laboratory testing of their SnoreStop NasoSpray, Homeopathic Anti-Snoring Nasal Spray. The product was found to be adulterated under section 501(a)(1) of the FD&C Act due to gross microbial contamination, with samples showing 420-6200 CFU/mL total aerobic microbial count and 30-3800 CFU/mL total yeast and mold counts, including *Providencia rettgeri*. This contamination is particularly concerning as the nasal spray is intended for use in children as young as five.

The firm's manufacturing methods, facilities, and controls were found to not conform to CGMP, rendering the product adulterated under section 501(a)(2)(B). Specifically, Green Pharmaceuticals failed to test finished drug products for objectionable microorganisms (21 CFR 211.165(b)), relying solely on their contract manufacturer's certificate of analysis for bulk product. The firm only began testing after FDA informed them of the contamination.

Furthermore, SnoreStop was identified as an unapproved new drug under section 505 of the FD&C Act, violating sections 301(d) and 505(a), as it is not generally recognized as safe and effective and lacks an FDA-approved application.

Green Pharmaceuticals conducted a voluntary recall of lot